JP2019524671A - 抗cd19抗体製剤 - Google Patents

抗cd19抗体製剤 Download PDF

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Publication number
JP2019524671A
JP2019524671A JP2018567742A JP2018567742A JP2019524671A JP 2019524671 A JP2019524671 A JP 2019524671A JP 2018567742 A JP2018567742 A JP 2018567742A JP 2018567742 A JP2018567742 A JP 2018567742A JP 2019524671 A JP2019524671 A JP 2019524671A
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Japan
Prior art keywords
concentration
formulation
antibody
polysorbate
sequence
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Pending
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JP2018567742A
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English (en)
Japanese (ja)
Inventor
ガリデル,パトリック
ランゲル,アンドレアス
ヘスリング,マルティン
ヴァインフルトナー,ダニエル
ブロックス,ボド
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MorphoSys GmbH
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MorphoSys GmbH
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Application filed by MorphoSys GmbH filed Critical MorphoSys GmbH
Publication of JP2019524671A publication Critical patent/JP2019524671A/ja
Priority to JP2022081779A priority Critical patent/JP7603201B2/ja
Priority to JP2024083988A priority patent/JP2024109816A/ja
Pending legal-status Critical Current

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/549Sugars, nucleosides, nucleotides or nucleic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2018567742A 2016-06-27 2017-06-27 抗cd19抗体製剤 Pending JP2019524671A (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2022081779A JP7603201B2 (ja) 2016-06-27 2022-05-18 抗cd19抗体製剤
JP2024083988A JP2024109816A (ja) 2016-06-27 2024-05-23 抗cd19抗体製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16176322.2 2016-06-27
EP16176322 2016-06-27
PCT/EP2017/065819 WO2018002031A1 (en) 2016-06-27 2017-06-27 Anti-cd19 antibody formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022081779A Division JP7603201B2 (ja) 2016-06-27 2022-05-18 抗cd19抗体製剤

Publications (1)

Publication Number Publication Date
JP2019524671A true JP2019524671A (ja) 2019-09-05

Family

ID=56368805

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2018567742A Pending JP2019524671A (ja) 2016-06-27 2017-06-27 抗cd19抗体製剤
JP2022081779A Active JP7603201B2 (ja) 2016-06-27 2022-05-18 抗cd19抗体製剤
JP2024083988A Pending JP2024109816A (ja) 2016-06-27 2024-05-23 抗cd19抗体製剤

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2022081779A Active JP7603201B2 (ja) 2016-06-27 2022-05-18 抗cd19抗体製剤
JP2024083988A Pending JP2024109816A (ja) 2016-06-27 2024-05-23 抗cd19抗体製剤

Country Status (26)

Country Link
US (2) US11352423B2 (enExample)
EP (2) EP3909985A1 (enExample)
JP (3) JP2019524671A (enExample)
KR (2) KR102533875B1 (enExample)
CN (2) CN115998859A (enExample)
AU (2) AU2017289085B2 (enExample)
CA (1) CA3029137A1 (enExample)
CY (1) CY1124521T1 (enExample)
DK (1) DK3475303T3 (enExample)
ES (1) ES2874640T3 (enExample)
HR (1) HRP20210945T1 (enExample)
HU (1) HUE054296T2 (enExample)
IL (1) IL263764B2 (enExample)
LT (1) LT3475303T (enExample)
MA (1) MA45450B1 (enExample)
MD (1) MD3475303T2 (enExample)
MX (1) MX2018016362A (enExample)
PL (1) PL3475303T3 (enExample)
PT (1) PT3475303T (enExample)
RS (1) RS62035B1 (enExample)
RU (1) RU2748024C2 (enExample)
SG (2) SG10201912369QA (enExample)
SI (1) SI3475303T1 (enExample)
SM (1) SMT202100317T1 (enExample)
WO (1) WO2018002031A1 (enExample)
ZA (1) ZA201900483B (enExample)

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AU2016311136B2 (en) 2015-08-21 2022-02-17 Incyte Corporation Combinations and uses thereof
LT3532098T (lt) 2016-10-28 2021-06-25 Morphosys Ag Anti cd19 antikūno derinys su bcl-2 inhibitoriumi, ir jo naudojimas
KR20200030337A (ko) 2018-09-12 2020-03-20 주식회사 녹십자랩셀 종양 치료를 위한 항-cd 19 항체 및 자연살해세포를 포함하는 약학적 조합물
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
WO2021067598A1 (en) 2019-10-04 2021-04-08 Ultragenyx Pharmaceutical Inc. Methods for improved therapeutic use of recombinant aav
AU2020372646A1 (en) 2019-10-31 2022-05-12 Incyte Corporation Anti-tumor combination therapy comprising anti-CD19 antibody and gamma delta T-cells
JP2023530499A (ja) 2020-06-22 2023-07-18 モルフォシス・アーゲー 抗CD19抗体及びSIRPα-CD47自然免疫チェックポイントを遮断するポリペプチドを含む抗腫瘍組み合わせ療法
AU2021357841A1 (en) 2020-10-08 2023-06-15 Affimed Gmbh Trispecific binders
AU2022320948A1 (en) 2021-07-30 2024-01-18 Affimed Gmbh Duplexbodies
WO2023073645A1 (en) 2021-10-29 2023-05-04 Takeda Pharmaceutical Company Limited Therapy comprising anti-cd19 antibody and sumo-activating enzyme inhibitor
EP4426439A1 (en) 2021-11-03 2024-09-11 Affimed GmbH Bispecific cd16a binders
AU2023264582A1 (en) * 2022-05-03 2024-11-21 Incyte Corporation Methods for treating lymphoma
EP4572756A1 (en) 2022-08-17 2025-06-25 Incyte Corporation Therapy comprising anti-cd19 antibody and ezh2 modulators
IL322510A (en) * 2023-03-02 2025-10-01 Novetide Ltd Method for preparing GLP-1 peptides with controlled particle size
CN120754244B (zh) * 2025-09-10 2025-12-12 江苏豪森药业集团有限公司 一种含抗cd19抗体的药物组合物及其用途

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WO2015157286A1 (en) * 2014-04-07 2015-10-15 Seattle Genetics, Inc. Stable formulations for anti-cd19 antibodies and antibody-drug conjugates

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Also Published As

Publication number Publication date
ZA201900483B (en) 2021-06-30
AU2017289085B2 (en) 2024-07-18
WO2018002031A1 (en) 2018-01-04
IL263764B1 (en) 2024-05-01
CN115998859A (zh) 2023-04-25
ES2874640T3 (es) 2021-11-05
NZ748681A (en) 2025-06-27
KR20190021373A (ko) 2019-03-05
KR20230074823A (ko) 2023-05-31
IL263764B2 (en) 2024-09-01
EP3475303B1 (en) 2021-04-14
HUE054296T2 (hu) 2021-08-30
EP3909985A1 (en) 2021-11-17
HRP20210945T1 (hr) 2021-09-17
PT3475303T (pt) 2021-06-25
RU2019100221A3 (enExample) 2020-11-30
AU2024205042A1 (en) 2024-08-15
MD3475303T2 (ro) 2021-09-30
MX2018016362A (es) 2019-04-22
AU2017289085A1 (en) 2018-12-13
SMT202100317T1 (it) 2021-07-12
US11352423B2 (en) 2022-06-07
CA3029137A1 (en) 2018-01-04
CN109415440A (zh) 2019-03-01
LT3475303T (lt) 2021-06-25
SG11201810429UA (en) 2018-12-28
IL263764A (en) 2019-01-31
SG10201912369QA (en) 2020-02-27
RS62035B1 (sr) 2021-07-30
SI3475303T1 (sl) 2021-12-31
RU2019100221A (ru) 2020-07-28
US20220213190A1 (en) 2022-07-07
KR102533875B1 (ko) 2023-05-18
CN109415440B (zh) 2022-12-06
CY1124521T1 (el) 2022-07-22
EP3475303A1 (en) 2019-05-01
PL3475303T3 (pl) 2021-12-06
MA45450B1 (fr) 2021-04-30
US20190322742A1 (en) 2019-10-24
JP7603201B2 (ja) 2024-12-20
DK3475303T3 (da) 2021-05-31
JP2022119854A (ja) 2022-08-17
RU2748024C2 (ru) 2021-05-19
JP2024109816A (ja) 2024-08-14

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